Trial Conduct

Scope

The Trial Conduct Working Group covers a wide range of aspects of trials. A Core Group, whose members represent each of the Hubs carrying out research into trial conduct as well as other important groups who are active in this field, meets regularly to facilitate and develop collaborative research into trial conduct. Recent activities have focussed on trial monitoring and the role of Trial Steering Committees. The latter includes new collaborative research which arose in response to issues raised in the HTMR’s engagement with one of our key stakeholders, the National Institute for Health Research Health Technology Assessment programme.

Future objectives

The Working Group will continue to focus on making trials more efficient and cost-effective, and in providing a link point between the HTMR Network and other organisations, including responding to recent consultations on the EU Clinical Trials Directive and access to data from trials. Its members are working on a variety of projects, including the SWAT (Study Within a Trial) programme, which was established by the All-Ireland Hub in 2012, along with its its sibling: Study Within A Review (SWAR). It aims to facilitate the embedding of methodology research in clinical trials and other prospective studies, by providing free access to the outlines for numerous SWAT and details of those that have been carried out. The first SWAT outline was published in the Journal of Evidence Based Medicine in 2013, to investigate the impact of a site visit by the principal investigator in a multi-centre trial, and the findings were reported in 2015. The development of the SWAT collection was supported by an award from the Medical Research Council's Network of Hubs for Trials Methodology Research (MR/L004933/1-R50) in 2014 and a session at the 3rd International Clinical Trials Methodology Conference in November 2015 highlighted the initative and several examples. As of May 2016, more than 40 SWAT and SWAR have been registered with the Northern Ireland Hub. You can find their outlines, and information on how to register a SWAT or a SWAR, including an online form, at go.qub.ac.uk/SWAT-SWAR.